Background: SGLT2 inhibitors reduce CHF morbidity/mortality but are underutilized in elderly patients with acute decompensated CHF (ADCHF) admitted outside cardiology departments.
Objective: Assess feasibility of early ED-initiated gliflozin therapy in elderly ADCHF patients.
Design: Multicenter, randomized, open-label pilot study; N=144 patients (72 per arm) across 6 EDs over 30 months.
Population: Age ≥75 years, ED admission for ADCHF (symptomatic worsening, congestion, elevated natriuretic peptides), gliflozin-naïve, requiring hospitalization.
Key Exclusions: Type 1 diabetes, eGFR \<25 mL/min/1.73m², cardiogenic shock, recent ACS, cardiology ward admission.
Intervention:
Treatment: Dapagliflozin 10mg daily within 24h + cardiac nurse telephone follow-up at 1 month Control: Standard care only Primary Outcome: Feasibility (organizational implementation, acceptability, protocol adherence, timeline compliance).
Follow-up: 7-day visit (clinical assessment, NT-proBNP, echocardiography) and 3-month cardiology consultation (mortality, rehospitalization, QoL, biomarkers, safety parameters).
Age ≥ 75 years
Worsening CHF symptoms (dyspnea, fatigue, weight gain, edema)
Objective signs of peripheral/pulmonary congestion
Sinus rhythm: BNP ≥ 400 pg/mL or NT-proBNP ≥ 1,600 pg/mL
Type 1 diabetes
Chronic kidney disease (eGFR < 25ml/min/1.73m²)
Cardiogenic shock
Acute coronary syndrome (current or within 30 days)
Parallel
Early initiation of dapagliflozin 10mg daily within 24h of emergency department admission
DrugEarly initiation of dapagliflozin 10mg daily within 24h of ED admission
Telephone follow-up by cardiac nurse practitioner at 1 month
Other interventionTelephone follow-up by cardiac nurse practitioner at 1 month
Standard acute decompensated heart failure care
Other interventionStandard acute decompensated heart failure care
Organizational feasibility: Implementation of procedures
Successful implementation of study procedures (yes/no). Binary assessment of whether study procedures were successfully implemented at each site.
Organizational feasibility: Patient flow assessment
Proportion of eligible patients successfully enrolled. Ratio of patients enrolled to patients screened, expressed as percentage.
Acceptability: Number of refusals
Number of patients refusing participation. Total count of eligible patients who declined to participate.
Acceptability: Reasons for refusal
Categories of refusal reasons. Qualitative categorization of stated reasons for study refusal.
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